A Randomized, Double-Blind Study of the Time Course of Response to Biphentin Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting.

A Randomized, Double-Blind Study of the Time Course of Response to Biphentin Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting.

Completed

Phase of Trial:
Phase III

Latest Information Update:22 May 2015

At a glance

Drugs
Methylphenidate (Primary)

Indications
Attention-deficit hyperactivity disorder

Focus
Registrational; Therapeutic Use

Sponsors
Rhodes Pharmaceuticals

Most Recent Events

22 May 2015
Aptensio XR [methyphenidate extended release] was approved by the U.S. FDA based on the data from this and another phase III trial [see CT profile 700191334].

22 May 2015
Primary endpoint of 'Comparison following treatment between drug and placebo using evaluation by SKAMP Combined, Attention, and Deportment Scales' has been met, according to a Rhodes Pharmaceuticals media release.